methadone hydrochloride

Generic: methadone hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methadone hydrochloride 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-5755
Product ID 0406-5755_72ab3c44-1cd7-41e9-8b6a-e030fdf65bc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040517
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2004-04-27

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04065755
Hyphenated Format 0406-5755

Supplemental Identifiers

RxCUI
864706 864718
UPC
0304065755012 0304065771012
UNII
229809935B

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methadone hydrochloride (source: ndc)
Generic Name methadone hydrochloride (source: ndc)
Application Number ANDA040517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-5755-01)
  • 1 TABLET in 1 BLISTER PACK (0406-5755-23)
  • 100 TABLET in 1 BLISTER PACK (0406-5755-62)
source: ndc

Packages (3)

0406-5755-01 100 TABLET in 1 BOTTLE (0406-5755-01) 0406-5755-23 1 TABLET in 1 BLISTER PACK (0406-5755-23) 0406-5755-62 100 TABLET in 1 BLISTER PACK (0406-5755-62)

Ingredients (1)

methadone hydrochloride (5 mg/1)

Linked Drug Pages (1)

METHADONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "72ab3c44-1cd7-41e9-8b6a-e030fdf65bc2", "openfda": {"upc": ["0304065755012", "0304065771012"], "unii": ["229809935B"], "rxcui": ["864706", "864718"], "spl_set_id": ["eddf7077-02fb-4771-9823-31984f4ff2bb"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-5755-01)", "package_ndc": "0406-5755-01", "marketing_start_date": "20040427"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-5755-23)", "package_ndc": "0406-5755-23", "marketing_start_date": "20040427"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (0406-5755-62)", "package_ndc": "0406-5755-62", "marketing_start_date": "20040427"}], "brand_name": "METHADONE HYDROCHLORIDE", "product_id": "0406-5755_72ab3c44-1cd7-41e9-8b6a-e030fdf65bc2", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-5755", "dea_schedule": "CII", "generic_name": "METHADONE HYDROCHLORIDE", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHADONE HYDROCHLORIDE", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA040517", "marketing_category": "ANDA", "marketing_start_date": "20040427", "listing_expiration_date": "20261231"}